Proposed Collection; 60-Day Comment Request Information Program on Clinical Trials: Maintaining a Registry and Results Databank (National Library of Medicine), 68508-68509 [2022-24859]
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68508
Federal Register / Vol. 87, No. 219 / Tuesday, November 15, 2022 / Notices
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS.)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
comments in writing, or request more
information on the proposed project,
contact: Christeenna Iraheta, Office of
Administrative and Management
Analysis Services, National Library of
Medicine, Building 38A, Room
B2N12A, 8600 Rockville Pike, Bethesda,
MD 20894, or call non-toll-free number
(301) 827–6361, or Email your request,
including your address to:
Christeenna.iraheta@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
National Institutes of Health
SUPPLEMENTARY INFORMATION:
Dated: November 9, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–24824 Filed 11–14–22; 8:45 am]
BILLING CODE 4140–01–P
Proposed Collection; 60-Day Comment
Request Information Program on
Clinical Trials: Maintaining a Registry
and Results Databank (National Library
of Medicine)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Library of Medicine (NLM),
National Institutes of Health (NIH), will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
with 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
SUMMARY:
Medicine (NLM), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The National Institutes of
Health operates ClinicalTrials.gov,
which was established as a clinical trial
registry under section 113 of the Food
and Drug Administration Modernization
Act of 1997 (Pub. L. 105–115) and was
expanded to include a results data bank
by Title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) and by the Clinical
Trials Registration and Results
Information Submission regulations at
42 CFR part 11. ClinicalTrials.gov
collects registration and results
information for clinical trials and other
types of clinical studies (e.g.,
observational studies and patient
registries) with the objectives of
enhancing patient enrollment and
providing a mechanism for tracking
subsequent progress of clinical studies
to the benefit of public health. It is
widely used by patients, physicians,
and medical researchers; in particular
those involved in clinical research.
While many clinical studies are
registered and submit results
information voluntarily, 42 CFR part 11
requires the registration of certain
applicable clinical trials of drug,
biological, and device products and the
submission of results information for
completed applicable clinical trials of
drug, biological, and device products
whether or not they are approved,
licensed, or cleared by the Food and
Drug Administration.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
1,219,801.
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Proposed Collection Title: Information
Program on Clinical Trials: Maintaining
a Registry and Results Databank, 0925–
0586, Expiration Date: 02/28/2023,
EXTENSION, National Library of
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Submission type
Number of
responses per
respondent
Average
time per
response
(in hours)
Total annual
burden hours
Registration—attachment 2
lotter on DSK11XQN23PROD with NOTICES1
Initial .................................................................................................................
Updates ............................................................................................................
Triggered, voluntary .........................................................................................
Initial, non-regulated, NIH Policy .....................................................................
Updates, non-regulated, NIH Policy ................................................................
Initial, voluntary and non-regulated .................................................................
Updates, voluntary and non-regulated ............................................................
7,400
7,400
141
940
940
17,860
17,860
1
8
1
1
8
1
8
8
2
8
8
2
8
2
59,200
118,400
1,128
7,520
15,040
142,880
285,760
1
2
1
1
2
1
40
10
45
40
10
40
296,000
148,000
2,115
37,600
18,800
56,000
Results Information Submission—attachment 5
Initial .................................................................................................................
Updates ............................................................................................................
Triggered, voluntary—also attachment 2 ........................................................
Initial, non-regulated, NIH Policy .....................................................................
Updates, non-regulated, NIH Policy ................................................................
Initial, voluntary and non-regulated .................................................................
VerDate Sep<11>2014
19:16 Nov 14, 2022
Jkt 259001
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
7,400
7,400
47
940
940
1,400
E:\FR\FM\15NON1.SGM
15NON1
68509
Federal Register / Vol. 87, No. 219 / Tuesday, November 15, 2022 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Submission type
Updates, voluntary and non-regulated ............................................................
Average
time per
response
(in hours)
Number of
responses per
respondent
Total annual
burden hours
1,400
2
10
28,000
Certification to delay results—attachment 6 ....................................................
Extension request and Appeals—attachment 7 ..............................................
Initial, expanded access—attachment 3 ..........................................................
Updates, expanded access—attachment 3 .....................................................
5,150
125
213
213
1
1
1
2
30/60
2
2
15/60
2,575
250
426
107
Total ..........................................................................................................
........................
271,122
........................
1,219,801
Other
Christeenna M. Iraheta,
Project Clearance Liaison, National Library
of Medicine, National Institutes of Health.
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
[FR Doc. 2022–24859 Filed 11–14–22; 8:45 am]
Dated: November 8, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2022–24770 Filed 11–14–22; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
lotter on DSK11XQN23PROD with NOTICES1
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Research Education
Program (R25 Clinical Trial Not Allowed).
Date: December 9, 2022.
Time: 10:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F40A,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Robert C. Unfer, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3F40A, Rockville, MD
20852, (240) 669–5035, robert.unfer@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
VerDate Sep<11>2014
19:16 Nov 14, 2022
Jkt 259001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G41, Rockville, MD
20852, 240–669–5067, kelly.hudspeth@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: November 8, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–24758 Filed 11–14–22; 8:45 am]
National Institutes of Health
BILLING CODE 4140–01–P
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Investigator Initiated
Program Project Applications (P01 Clinical
Trial Not Allowed).
Date: December 7, 2022.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G41,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Kelly L. Hudspeth, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; Using
Rodent Behavioral Models to Identify
Substance Abuse Pharmacotherapies.
Date: December 6, 2022.
Time: 4:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
National Institute on Drug Abuse, 301 North
E:\FR\FM\15NON1.SGM
15NON1
]]>Agencies
[Federal Register Volume 87, Number 219 (Tuesday, November 15, 2022)]
[Notices]
[Pages 68508-68509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24859]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request Information Program
on Clinical Trials: Maintaining a Registry and Results Databank
(National Library of Medicine)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Library of Medicine (NLM), National
Institutes of Health (NIH), will publish periodic summaries of proposed
projects to be submitted to the Office of Management and Budget (OMB)
for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received with 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Christeenna
Iraheta, Office of Administrative and Management Analysis Services,
National Library of Medicine, Building 38A, Room B2N12A, 8600 Rockville
Pike, Bethesda, MD 20894, or call non-toll-free number (301) 827-6361,
or Email your request, including your address to:
[email protected]. Formal requests for additional plans and
instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires written comments and/or suggestions from
the public and affected agencies are invited to address one or more of
the following points: (1) Whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) Ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) Ways
to minimize the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Proposed Collection Title: Information Program on Clinical Trials:
Maintaining a Registry and Results Databank, 0925-0586, Expiration
Date: 02/28/2023, EXTENSION, National Library of Medicine (NLM),
National Institutes of Health (NIH).
Need and Use of Information Collection: The National Institutes of
Health operates ClinicalTrials.gov, which was established as a clinical
trial registry under section 113 of the Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include
a results data bank by Title VIII of the Food and Drug Administration
Amendments Act of 2007 (FDAAA) and by the Clinical Trials Registration
and Results Information Submission regulations at 42 CFR part 11.
ClinicalTrials.gov collects registration and results information for
clinical trials and other types of clinical studies (e.g.,
observational studies and patient registries) with the objectives of
enhancing patient enrollment and providing a mechanism for tracking
subsequent progress of clinical studies to the benefit of public
health. It is widely used by patients, physicians, and medical
researchers; in particular those involved in clinical research. While
many clinical studies are registered and submit results information
voluntarily, 42 CFR part 11 requires the registration of certain
applicable clinical trials of drug, biological, and device products and
the submission of results information for completed applicable clinical
trials of drug, biological, and device products whether or not they are
approved, licensed, or cleared by the Food and Drug Administration.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 1,219,801.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Submission type Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Registration--attachment 2
----------------------------------------------------------------------------------------------------------------
Initial......................................... 7,400 1 8 59,200
Updates......................................... 7,400 8 2 118,400
Triggered, voluntary............................ 141 1 8 1,128
Initial, non-regulated, NIH Policy.............. 940 1 8 7,520
Updates, non-regulated, NIH Policy.............. 940 8 2 15,040
Initial, voluntary and non-regulated............ 17,860 1 8 142,880
Updates, voluntary and non-regulated............ 17,860 8 2 285,760
----------------------------------------------------------------------------------------------------------------
Results Information Submission--attachment 5
----------------------------------------------------------------------------------------------------------------
Initial......................................... 7,400 1 40 296,000
Updates......................................... 7,400 2 10 148,000
Triggered, voluntary--also attachment 2......... 47 1 45 2,115
Initial, non-regulated, NIH Policy.............. 940 1 40 37,600
Updates, non-regulated, NIH Policy.............. 940 2 10 18,800
Initial, voluntary and non-regulated............ 1,400 1 40 56,000
[[Page 68509]]
Updates, voluntary and non-regulated............ 1,400 2 10 28,000
----------------------------------------------------------------------------------------------------------------
Other
----------------------------------------------------------------------------------------------------------------
Certification to delay results--attachment 6.... 5,150 1 30/60 2,575
Extension request and Appeals--attachment 7..... 125 1 2 250
Initial, expanded access--attachment 3.......... 213 1 2 426
Updates, expanded access--attachment 3.......... 213 2 15/60 107
---------------------------------------------------------------
Total....................................... .............. 271,122 .............. 1,219,801
----------------------------------------------------------------------------------------------------------------
Christeenna M. Iraheta,
Project Clearance Liaison, National Library of Medicine, National
Institutes of Health.
[FR Doc. 2022-24859 Filed 11-14-22; 8:45 am]
BILLING CODE 4140-01-P
